Peripheral Arterial DiseaseNCT03763357
Acute Effects of Leg Heating on Skeletal Muscle Blood Flow
A study testing Heat Therapy (HT) in people with Peripheral Arterial Disease, run by Indiana University.
Trial summary
The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study direct measurement of blood flow in the legs pre and post heat treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Heat Therapy (HT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women with a stable symptomatic claudication for >/= 6 months
- Ankle brachial index < 0.9
Who cannot join
- Uncontrolled diabetes
- Heart failure
- COPD
- Critical limb ischemia
- Prior amputation
- Exercise-limiting co-morbidity
Show all 17Show fewer
- Recent (< 3 months) intra-inguinal revascularization or planned in study period
- Plans to change medical therapy during duration of study
- Active cancer
- Chronic kidney disease (eGFR < 30)
- HIV positive, active HBV or HCV disease
- Presence of an clinical condition that makes the patient not suitable to participate in the trial
- Peripheral neuropathy, numbness or paresthesia in the legs
- Morbid obesity BMI > 36 or unable to fit into water-circulating pants
- Open wounds or ulcers on the extremity
- Claustrophobia/unable to tolerate PET/CT scanning
- Women of child-bearing age
About this study
Official title: Acute Effects of Leg Heating on Skeletal Muscle Blood Flow in Patients With Symptomatic Peripheral Artery Disease
The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study direct measurement of blood flow in the legs pre and post heat treatment.
Read the detailed description
Cilostazol is the only effective medication available to treat walking pain (intermittent claudication) and it has multiple side effects. Overall improvement in walking performance in patients who use cilostazol is small. Endovascular and surgical interventions are effective alternatives for patients who don't respond to medical therapy, however, these procedures are costly and only applicable to patients with certain lesions types and carry a high risk of restenosis.
Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to test the hypothesis that a single session of heat therapy will increase local muscle tissue blood flow in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.
Subjects who have met inclusion criteria will volunteer for a single experimental visit. Participants will wear the water circulating pants and asked to rest supine for 30 minutes inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of 62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute baseline period, after 45 minutes of heat therapy and at the end of the intervention (90 minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations will not interfere with acquisition of a subsequent PET scan at this timing interval.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Heat Therapy (HT)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Therapy (HT)Device
Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS.
| Study group | Role | What they receive |
|---|---|---|
| Heat Therapy | Experimental | Subject will dress in water-circulating trousers that are connected to a Heat Therapy (HT) pump. Warm water (42-43 degrees C) will be perfused through the pants for 90 minutes. Receives: Device: Heat Therapy (HT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in calf blood flow
Calf muscle perfusion rate (mL⋅min-1⋅g-1) will be obtained after administration of tracer 62Cu-ETS before, during and after exposure to heat therapy or a control intervention. Changes from in perfusion rate from baseline to 45 minutes and 90 minutes of heating or control will be measured.
Measured: Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Unable to obtain CT contrast from provider
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All of the subjects in this study will receive leg heat therapy.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Roseguini, Bruno, PhD, Purdue University
- Responsible party
- Principal investigator, Raghu Motaganahalli, Indiana University
- Investigators
- Raghu L Motaanahalli, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763357
- Sponsor's protocol ID
- 1809400414
- Status last verified
- Mar 2023
- First submitted
- 23 Nov 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Leg Heating on Skeletal Muscle Blood Flow in Patients With Symptomatic Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT03763357
- Acronym / sponsor ID
- 1809400414
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain CT contrast from provider
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Roseguini, Bruno, PhD, Purdue University
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study direct measurement of blood flow in the legs pre and post heat treatment.
Detailed description
Cilostazol is the only effective medication available to treat walking pain (intermittent claudication) and it has multiple side effects. Overall improvement in walking performance in patients who use cilostazol is small. Endovascular and surgical interventions are effective alternatives for patients who don't respond to medical therapy, however, these procedures are costly and only applicable to patients with certain lesions types and carry a high risk of restenosis.
Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to test the hypothesis that a single session of heat therapy will increase local muscle tissue blood flow in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.
Subjects who have met inclusion criteria will volunteer for a single experimental visit. Participants will wear the water circulating pants and asked to rest supine for 30 minutes inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of 62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute baseline period, after 45 minutes of heat therapy and at the end of the intervention (90 minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations will not interfere with acquisition of a subsequent PET scan at this timing interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All of the subjects in this study will receive leg heat therapy.
| Arm | Type | Receives |
|---|---|---|
| Heat Therapy | Experimental | Device: Heat Therapy (HT)Subject will dress in water-circulating trousers that are connected to a Heat Therapy (HT) pump. Warm water (42-43 degrees C) will be perfused through the pants for 90 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women with a stable symptomatic claudication for >/= 6 months
- Ankle brachial index < 0.9
Key exclusion criteria (17 listed)
- Uncontrolled diabetes
- Heart failure
- COPD
- Critical limb ischemia
- Prior amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat Therapy (HT)Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS. | Device | Heat Therapy |
Primary outcome
Change in calf blood flow
Time frame: Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen
Calf muscle perfusion rate (mL⋅min-1⋅g-1) will be obtained after administration of tracer 62Cu-ETS before, during and after exposure to heat therapy or a control intervention. Changes from in perfusion rate from baseline to 45 minutes and 90 minutes of heating or control will be measured.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghu L Motaanahalli, MD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Heat Therapy (HT) in people with Peripheral Arterial Disease, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in calf blood flow (time frame: Blood flow measurements will be completed at baseline (0 minutes) and after 45 and 90 minutes of exposure to heat therapy or a control regimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.